ASA Monitor October 2024, Vol. 88, 26.
Masimo W1® Medical Watch receives FDA 510(k) clearance for connectivity
Masimo announced that the Masimo W1® medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet® comprehensive telemonitoring solution. Masimo W1 Medical received FDA clearance last year as the first medical watch to provide continuous oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use at home and in hospitals. The combination of Masimo W1 Medical and Masimo SafetyNet allows patient data, collected via the wrist, to be made available on the Masimo SafetyNet smartphone app and reviewed by remote caregivers, including by hospital clinicians on the web-based Masimo SafetyNet clinician portal.
The clinical significance of Masimo W1 Medical comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates Signal Extraction Technology® pulse oximetry and rainbow® Pulse CO-Oximetry knowledge into a single wearable module. It has an integrated optical sensor and electrocardiogram (ECG) electrode pads that can be used to detect physiological signals. The Masimo MW-1 module also processes these signals using Masimo’s proprietary signal processing algorithms to output high-resolution SpO2, PR, perfusion index (Pi), and HR from an ECG.
The continuous data from the Masimo MW-1 module is displayed in real time on the Masimo W1 watch touchscreen. With the addition of Bluetooth connectivity, patients can use the Masimo SafetyNet app on their phone to input additional symptoms into CarePrograms designed by their clinicians, view their live data and trends, conduct virtual visits with clinicians, and view educational resources.
In turn, clinicians can examine data and trends and receive customized notifications within the Masimo SafetyNet clinician portal. With Masimo SafetyNet, clinicians can more easily track patient progress, tailor remote care programs to match each patient’s needs, and streamline their workflows with high-fidelity reports, rich analytics, and the integration of reliable medical data into electronic medical records (EMRs).
Source: asamonitor.pub/3X7loHn
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